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The Senior Threat Administration Specialist shall be answerable for growing, sustaining, and supporting the corporate’s risk management file. You’ll be a part of the event group of our imaging system, to search out the very best options to deal with challenges and implement a risk-based method to medical gadget improvement. Key obligations for this function embody Apply technical excellence and management for complicated programs to realize secure and efficient designs for brand new and present product platforms. Drive risk management actions, together with the incorporation of relevant medical requirements. Put together, current, and lead formal/casual opinions of outcomes, deigns, and analyses, and drive alignment with friends, mission group, and cross-functional stakeholders. Develop and replace Design Historical past File data to help each High quality and Regulatory documentation. Comply with design management processes whereas producing and reviewing risk management deliverables, together with: Threat Administration Plan; Recognized and foreseeable hazards; Threat Evaluation ({hardware}, software program, cybersecurity, usability, interoperability, and so on.); Warning labeling traceability; Traceability Report ({hardware}, software program, cybersecurity, usability, interoperability, and so on.); Threat Administration Report; Threat Controls; Threat Coverage; Harms Listing. What you supply Demonstrable understanding and software of Design Controls per 21 CFR 820.30 and Threat Administration per ISO 14971:2019. Demonstrable understanding and software of Design, Use and Manufacture risk-related evaluation methodologies, together with however not restricted to FMEAs, FTAs and Medical Hazard Evaluation. Palms-on mindset with problem-solving abilities and nice consideration to element additionally whereas multitasking. Capacity to work in cross-functional groups that span world operations Technical understanding of complicated technical programs involving mechanical and mechatronic programs, electronics, acoustics, software program, and sign processing. Expertise with intravascular catheter or minimally invasive gadget design and improvement is a plus. Demonstrated expertise in main inner and exterior improvement assets to realize product improvement objectives. Sturdy work ethic with a team-oriented mindset. Earlier Startup expertise is a plus. Glorious communication skills in English BE/BEng diploma in biomedical, mechanical, electrical, programs or software program engineering, publish graduate is a plus. What we provide Working in a start-up growing leading edge imaging programs bettering healthcare. Turning into a part of a dynamic, multi-national group of extremely expert people with a really robust give attention to group tradition and particular person improvement. A everlasting contract in an award-winning start-up. Versatile working setting and a global tradition in addition to workplaces in Germany and Eire.
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